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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00630110




Registration number
NCT00630110
Ethics application status
Date submitted
26/02/2008
Date registered
6/03/2008
Date last updated
16/08/2011

Titles & IDs
Public title
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Scientific title
Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
NPI-2358-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - docetaxel
Treatment: Drugs - NPI-2358 + docetaxel

Active Comparator: docetaxel - docetaxel (75 mg/m2)

Experimental: NPI-2358 + docetaxel - NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)


Treatment: Drugs: docetaxel
docetaxel (75 mg/m2)

Treatment: Drugs: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Timepoint [1] 0 0
Continuous
Secondary outcome [1] 0 0
Compare response rate, duration of response, 6-month survival, progression free survival and safety.
Timepoint [1] 0 0
Continuous
Secondary outcome [2] 0 0
Pharmacokinetics
Timepoint [2] 0 0
Continuous

Eligibility
Key inclusion criteria
- Male and females = 18 years of age

- ECOG performance status = 1

- Pathologically or histologically confirmed advanced non-small cell lung cancer
(unresectable Stage IIIb or IV) that has progressed after treatment with at least one
chemotherapy regimen; measurable disease is not required for enrollment into this
trial

- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have
resolved to Grade = 2

- Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Administration of certain chemotherapy, biological, immunotherapy, radiation therapy,
surgery or investigational agent within specified time frames

- Significant cardiac history

- Prior treatment with tumor vascular disruptive agents

- Seizure disorder

- Brain metastases

- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy

- Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or
C

- Patients with a prior hypersensitivity reaction to product components

- Pregnant or breast-feeding women.

- Concurrent, active second malignancy for which the patient is receiving therapy,
excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix

- Unwilling or unable to comply with procedures required in this protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
- Bendigo
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Bahia Blanca
Country [7] 0 0
Argentina
State/province [7] 0 0
Capital Federal
Country [8] 0 0
Argentina
State/province [8] 0 0
Cordoba
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Brazil
State/province [10] 0 0
Barretos
Country [11] 0 0
Brazil
State/province [11] 0 0
Curitiba
Country [12] 0 0
Brazil
State/province [12] 0 0
Ijui
Country [13] 0 0
Brazil
State/province [13] 0 0
Porte Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Chile
State/province [16] 0 0
Santiago
Country [17] 0 0
Chile
State/province [17] 0 0
Valparaiso
Country [18] 0 0
India
State/province [18] 0 0
W. Bengal
Country [19] 0 0
India
State/province [19] 0 0
Bangalore
Country [20] 0 0
India
State/province [20] 0 0
Chennai
Country [21] 0 0
India
State/province [21] 0 0
Hyderabad
Country [22] 0 0
India
State/province [22] 0 0
Jaipur
Country [23] 0 0
India
State/province [23] 0 0
Kolkata
Country [24] 0 0
India
State/province [24] 0 0
Mumbai
Country [25] 0 0
India
State/province [25] 0 0
Pune
Country [26] 0 0
India
State/province [26] 0 0
Vishakhapatnam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nereus Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with
docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new
blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting
agents are intended to target the differences between these tumor blood vessels and the blood
vessels in normal tissues.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00630110
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew A Spear, MD
Address 0 0
Chief Medical Officer, Nereus Pharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00630110